Pantoprazole Sodium D/r
NDC Package 61919-700-40

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Pantoprazole Sodium D/r is pantoprazole sodium delayed-release tablets are indicated for:1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). Marketed by Direct Rx, this product is identified by NDC 61919-700 and is authorized under FDA application ANDA090074.

Identification & Billing

NDC Package Code
61919-700-40
Package Description
40 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
61919-700
11-Digit Billing Format
61919070040
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
40 EA
RxNorm Crosswalk
  • RxCUI: 314200 - pantoprazole sodium 40 MG Delayed Release Oral Tablet
  • RxCUI: 314200 - pantoprazole 40 MG Delayed Release Oral Tablet
  • RxCUI: 314200 - pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Pantoprazole Sodium D/r
Dosage Form
-
Usage Information
Pantoprazole sodium delayed-release tablets are indicated for:1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.1.2 Maintenance of Healing of Erosive EsophagitisPantoprazole sodium delayed-release tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) SyndromePantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.

Regulatory & Marketing

Labeler Name
Direct Rx
FDA Application #
ANDA090074
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-11-2018
Listing Expiration
12-31-2024
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61919-700). Click a package code to view its specific billing and regulatory data.

61919-700-30
30 TABLET, DELAYED RELEASE in 1 BOTTLE
61919-700-90
90 TABLET, DELAYED RELEASE in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 61919-700-40 identifies a specific commercial package of 40 tablet, delayed release in 1 bottle of Pantoprazole Sodium D/r, labeled by Direct Rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 40 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Direct Rx on December 11, 2018. The current certification is valid through December 31, 2024.

How is this Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61919070040. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 40 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
61919-700-40
11-Digit CMS (5-4-2)
61919-0700-40

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.